Active ingredients: Benzylpenicillin benzathine
SYRINGES:
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection for intramuscular use (Benzylpenicillin Benzatin)
BOTTLES:
Sigmacillin 1,200,000 I.U./4 ml powder and solvent for suspension for injection for intramuscular use
Sigmacillin 1,200,000 I.U. powder for suspension for injection for intramuscular use
Sigmacillin 600,000 I.U./2.5 ml powder and solvent for suspension for injection for intramuscular use
Sigmacillin 600,000 I.U. powder for suspension for injection for intramuscular use (Benzylpenicillin Benzatin)
Why is Sigmacillin used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antibacterial for systemic use - Penicillins sensitive to ß-lactamases.
THERAPEUTIC INDICATIONS
Benzylpenicillin Benzatin is indicated in the treatment of infections caused by microorganisms sensitive to Benzylpenicillin and which respond to low but very persistent serum levels of the antibiotic. Prophylaxis of rheumatic disease and relapses, lue.
Contraindications When Sigmacillin should not be used
Hypersensitivity to the active substance or to any of the excipients; Hypersensitivity to penicillins, cephalosporins, beta-lactam antibiotics. Infections caused by penicillinase-producing germs.
Contraindicated in pregnancy and in children under 3 years of age (see Special warnings).
Precautions for use What you need to know before taking Sigmacillin
In patients treated with penicillin-containing preparations, severe reactions such as anaphylactic shock may occur, more frequently by parenteral administration but also by oral administration. The most exposed subjects are those who from the history are sensitive to various allergens. Before starting a treatment with penicillin, it is therefore necessary to investigate any previous manifestations of hypersensitivity to penicillins and / or cephalosporins, where they appear in the anamnesis, the drug it should not be administered. In case of a positive history of hypersensitivity to other allergens, on the other hand, the drug must be administered with extreme caution.
If allergic reactions occur during the course of treatment, the antibiotic should be discontinued and medications routinely used in these situations such as pressor amines, antihistamines and corticosteroids should be administered. Where necessary, vital functions should be supported by appropriate supportive measures.
The excretion of benzylpenicillin via the renal emunctorium is slowed in patients with renal insufficiency. High doses of β-lactamines, especially in subjects with renal insufficiency, can give rise to metabolic encephalopathies with disturbances of consciousness, abnormal movements, seizures. If any of the above reactions occur, penicillin administration should be discontinued unless the disease being treated is life-threatening and sensitive only to penicillin therapy.
Interactions Which drugs or foods can modify the effect of Sigmacillin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Administration of bacteriostatic antibiotics (e.g. erythromycin, tetracycline) can reduce the bactericidal effects of penicillins by slowing the rate of bacterial growth. It has been shown in vitro that bactericidal agents are most effective when they act on the immature cell wall of rapidly proliferating microorganisms. However, the clinical significance of this interaction is not well documented. There are few clinical situations in which this is indicated. concomitant use of bacteriostatic and bactericidal antibiotics. However, in selected circumstances where such therapy is appropriate, the potential for interaction should be minimized by the use of adequate doses of antibacterials and by initiating treatment with penicillin first.
Blood levels of penicillin may be prolonged by concomitant administration of probenecid which blocks renal tubular secretion of penicillins.
Warnings It is important to know that:
Injection into or near nerves or blood vessels is dangerous as it can cause neurovascular lesions. The physico-chemical characteristics of Benzylpenicillin Benzatin require particular attention to correct methods of use (see Dose, method and time of administration) and recommend reserving use by adults and children who are at least three years old. In the latter, moreover, the lateral aspect of the thigh (vastus lateral muscle of the quadriceps femoris) will be preferred as the injection site.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The medicine is contraindicated in pregnancy. During lactation, the medicine should be administered in cases of real need and under the direct supervision of the doctor.
Important information about some of the ingredients:
the suspension for injection in pre-filled syringes contains para-hydroxy-benzoates, as preservatives, which can cause allergic reactions, even delayed ones, and exceptionally bronchospasm.
Dosage and method of use How to use Sigmacillin: Dosage
Infections of the upper respiratory tract: (acute tonsillitis, pharyngitis, etc.) sustained by group A streptococci: a single injection of 1,200,000 I.U. for adults and a variable dose between 300,000 and 900,000 I.U. in children.
Venereal infections: primary, secondary and latent syphilis: 2,400,000 I.U. in a single administration; tertiary syphilis and neurosyphilis: 2,400,000 IU every 7 days three times (7,200,000 IU); blenorrhagia: 1,200,000 units in a single administration.
Prophylaxis of rheumatic fever: 600,000 I.U. to be repeated every two weeks or 1,200,000 I.U. every month.
Benzylpenicillin Benzatin is injected exclusively intramuscularly.
It is intended for use only for adults and children over the age of three. In children, the lateral aspect of the thigh (vastus lateral quadriceps femoris muscle) is preferred as the injection site.
Instructions for use for syringes
Suspension for injection for intramuscular use in pre-filled syringes: the suspension is ready for use
Given the high concentration of material in suspension, the product can cause obstruction of the needle and difficulties in administration. The package includes two types of needle, a green needle (21 G) and a pink needle (18 G). The smaller gauge needle (green) is the proper needle for administration, however to limit the difficulties mentioned it is possible to use a larger needle (18 G) which is supplied as an alternative.
Following some simple precautions can facilitate administration:
- The product must be taken out of the refrigerator at least 2 hours before being administered.
- The product must be brought to a temperature suitable for administration, i.e. to a temperature close to body temperature. Make sure that this temperature is also reached by the needle that accompanies the package (it will be enough to rotate the syringe between the two hands for more than 3 minutes and hold the needle in its sachet in hand).
- Shake vigorously before use for more than 3 minutes. When the product is ready for use, the suspension inside the syringe appears uniform and fluid.
- The syringe must not contain air before the injection, insert the 21G green needle or the pink 18G needle, push the plunger until the product appears on the tip of the needle, which is by its nature white in color and creamy consistency.
- Given the microcrystalline nature of Benzylpenicillin Benzatin, it is absolutely essential, to avoid serious embolic incidents (particularly in children) that the injection is given only after making sure that the needle has not accidentally penetrated a vein or an artery by carrying out the usual suction maneuver. Inject in the upper part of the buttock.
- The pressure of the finger on the plunger of the syringe must be higher than that traditionally required for non-suspended products.
- Administration should be done slowly, steadily and without interruption. If during the injection a resistance to the pressure of the piston is felt (possible indicator of obstruction of the needle due to the formation of crystalline agglomerates) or the patient experiences acute local pain, immediately interrupt the injection itself and remove the needle, let out a drop of product from the syringe without needle, insert a new needle and make a new injection. The choice of the type of needle to be replaced can follow the criteria indicated above. For this purpose, double needles of both types (18G and 21G) are supplied.
- It is recommended to have it administered by an experienced medical or nursing staff.
- If not all the contents of the syringe are used, the remainder should be discarded and not reused.
Instructions for use for the bottles
Powder for suspension for injection for intramuscular use: the suspension must be prepared extemporaneously by combining the solvent present in the package with the powder. Then shake the vial containing the suspension vigorously for a long time and draw into the syringe. The reconstituted suspension should be injected immediately after preparation.
Given the microcrystalline nature of Benzylpenicillin Benzatin, it is absolutely essential, to avoid serious embolic incidents (particularly in children) that the injection is given only after making sure that the needle has not accidentally penetrated a vein or an artery.
For greater safety, it is suggested to this end, before injecting, to discard the needle used to fill the syringe and to insert a new needle only of No. 2 (21G) into the muscle mass, waiting at least 15 seconds to observe a " possible bleeding. Only if this is not the case, insert the syringe into the needle. Carry out the usual aspiration maneuver.
If during the injection a resistance to the pressure of the piston is felt (possible indicator of obstruction of the needle due to the formation of crystalline agglomerates) or the patient experiences acute local pain, immediately stop the injection itself and discard the liquid not yet used proceeding if necessary to give a new injection with a new needle and a new vial.
When repeated doses are required, the injection site should be changed from time to time.
Overdose What to do if you have taken too much Sigmacillin
In case of accidental intake of an excessive dose of Sigmacillin, notify your doctor immediately or go to the nearest hospital.
Overdose can lead to neurological adverse reactions, with elevated levels of beta-lactams in the CSF. In case of overdose, institute symptomatic treatment and take supportive measures.
Benzylpenicillin is hemodialysable.
If you have any questions about the use of Sigmacillin, ask your doctor or pharmacist.
Side Effects What are the side effects of Sigmacillin
Like all medicines, Sigmacillin can cause side effects, although not everybody gets them.
Below are the side effects of Benzylpenicillin Benzatin. Insufficient data are available to establish the frequency of the individual effects listed.
Skin and subcutaneous tissue disorders: maculopapular rash, exfoliative dermatitis, urticaria, Quincke's edema, edema
Musculoskeletal and connective tissue disorders: arthralgia
General disorders and administration site conditions: hyperthermia, prostration
Immune system disorders: serum sickness with chills, cases of Jarish-Herxheimer reaction, exceptionally anaphylactic shock have been reported in antiluetic treatments
Gastrointestinal disorders: glossitis, stomatitis, nausea, vomiting, diarrhea (more frequent following oral administration)
Blood and lymphatic system disorders: anemia, thrombocytopenia, leukopenia, eosinophilia (usually following high doses)
Investigations: increased transaminases
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
WARNING: do not use the medicine after the expiry date indicated on the package.
Storage conditions:
SYRINGES
Suspension for injection for intramuscular use
Store at 2 ° C to 8 ° C (refrigerated) in the original package to protect from light.
BOTTLES
Powder and solvent for suspension for injection for intramuscular use
Powder for suspension for injection for intramuscular use
Store at a temperature not exceeding 25 ° C in the original package to protect the medicine from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN.
Other information
COMPOSITION
SYRINGES
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection for intramuscular use
- One 2.5 ml pre-filled syringe contains:
- Active ingredient: Benzylpenicillin Benzatin 1,200,000 I.U.
- Excipients: Lecithin; Povidone; Sodium Citrate; Sodium caramelose; Propyl parahydroxybenzoate E216; Methyl parahydroxybenzoate E218; Water for injections.
BOTTLES
Sigmacillin 1,200,000 I.U./4 ml powder and solvent for suspension for injection for intramuscular use
One vial of powder contains:
- Active ingredient: Benzylpenicillin Benzatin 1,200,000 I.U.
- Excipients: the vial of powder contains: Lecithin; Polysorbate.
- The solvent vial contains: water for injections.
Sigmacillin 1,200,000 I.U. powder for suspension for injection for intramuscular use
One vial of powder contains:
- Active ingredient: Benzylpenicillin Benzatin 1,200,000 I.U.
- Excipients: Lecithin; Polysorbate.
Sigmacillin 600,000 I.U./2.5 ml powder and solvent for suspension for injection for intramuscular use
One vial of powder contains:
- Active ingredient: Benzylpenicillin Benzatin 600,000 I.U.
- Excipients: the vial of powder contains: Lecithin; Polysorbate.
- The solvent vial contains: water for injections.
Sigmacillin 600,000 I.U. powder for suspension for injection for intramuscular use
One vial of powder contains:
- Active ingredient: Benzylpenicillin Benzatin 600,000 I.U.
- Excipients: Lecithin; Polysorbate.
PHARMACEUTICAL FORM AND CONTENT
SYRINGES
Suspension for injection for intramuscular use
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection for intramuscular use.
Carton of 1, 2 or 6 pre-filled syringes of 2.5 ml - with 4, 8 or 24 sterile needles (18G and 21G) respectively.
BOTTLES
Powder and solvent for suspension for injection for intramuscular use
Sigmacillin 600,000 I.U./2.5 ml powder and solvent for suspension for injection for intramuscular use.
Carton of 1 vial of powder + 1 solvent vial of 2.5 ml
Sigmacillin 1,200,000 I.U./4 ml powder and solvent for suspension for injection for intramuscular use.
Carton of 1 vial of powder + 1 solvent vial of 4 ml
Powder for suspension for injection for intramuscular use
Sigmacillin 600,000 I.U. powder for suspension for injection for intramuscular use
Sigmacillin 1,200,000 I.U. powder for suspension for injection for intramuscular use.
Box of 50 or 100 vials of powder.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SIGMACILLIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
SYRINGES
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection for use
intramuscular
One 2.5 ml pre-filled syringe contains:
Active principle: Benzylpenicillin Benzatin 1,200,000 I.U.
Excipients: Propylparahydroxybenzoate E216; Methyl parahydroxybenzoate E218
BOTTLES
Sigmacillin 1,200,000 U.I./4 ml powder And solvent for suspension for injection for intramuscular use.
One vial of powder contains:
Active principle: Benzylpenicillin Benzatin 1,200,000 I.U.
Sigmacillin 1,200,000 U.I. powder for suspension for injection for use
intramuscular
One vial of powder contains:
Active principle: Benzylpenicillin Benzatin 1,200,000 I.U.
Sigmacillin 600,000 U.I./2,5 ml powder And solvent for suspension
injectable for intramuscular use
One vial of powder contains:
Active principle : Benzylpenicillin Benzatin 600,000 I.U.
Sigmacillin 600,000 U.I. powder for suspension
injectable for intramuscular use
One vial of powder contains:
Active principle : Benzylpenicillin Benzatin 600,000 I.U.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Powder and solvent for suspension for injection for intramuscular use.
Powder for suspension for injection for intramuscular use.
Suspension for injection for intramuscular use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Benzylpenicillin Benzatin is indicated in the treatment of infections caused by microorganisms sensitive to Benzylpenicillin, which respond to low, but very prolonged, serum levels of the antibiotic. Prophylaxis of rheumatic disease and relapses. Lue.
04.2 Posology and method of administration
Infections of the upper respiratory tract: (acute tonsillitis, pharyngitis, etc.) sustained by group A streptococci: a single injection of 1,200,000 I.U. for adults and a variable dose between 300,000 and 900,000 I.U. in children.
Venereal infections: primary, secondary and latent syphilis: 2,400,000 I.U. in a single administration; tertiary syphilis and neurosyphilis: 2,400,000 IU every 7 days three times (7,200,000 IU); blenorrhagia: 1,200,000 IU in a single administration.
Prophylaxis of rheumatic fever: 600,000 I.U. to be repeated every two weeks or 1,200,000 I.U. every month.
Benzylpenicillin Benzatin is injected exclusively intramuscularly.
The use is reserved for adults and children over three years of age.
In children, the lateral aspect of the thigh is preferred (vastus lateral muscle of the quadriceps femoris) as the injection site.
Instructions for Use for syringes
Suspension for injection for intramuscular use in pre-filled syringes : the suspension is ready for use.
Given the high concentration of material in suspension, the product can cause obstruction of the needle and difficulties in administration.
The package includes two types of needle, a green needle (21 G) and a pink needle (18 G). The smaller gauge needle (green) is the proper needle for administration, however to limit the difficulties mentioned it is possible to use a larger needle (18 G) which is supplied as an alternative.
Following some simple precautions can facilitate administration:
• The product must be taken out of the refrigerator at least 2 hours before being administered.
• The product must be brought to a temperature suitable for administration, ie a temperature close to body temperature. Make sure that this temperature is also reached by the needle that accompanies the package (it will be enough to rotate the syringe between the two hands for more than 3 minutes and hold the needle in its sachet in hand).
• Shake vigorously before use for more than 3 minutes. When the product is ready for use, the suspension inside the syringe appears uniform and fluid.
• To insert the needle it is necessary to remove the plastic cap of the syringe by breaking the seal as shown below.
• The syringe must not contain air before the injection, insert the 21G green needle or the pink 18G needle, push the plunger until the product appears on the tip of the needle, which is by its nature white in color and creamy consistency .
• Given the microcrystalline nature of Benzylpenicillin Benzatin, it is absolutely essential to avoid serious embolic incidents (particularly in children) that the injection is given only after making sure that the needle has not accidentally entered a vein or an artery by carrying out the usual aspiration maneuver.
Inject in the upper part of the buttock.
• The pressure of the finger on the plunger of the syringe must be higher than that traditionally required for non-suspended products.
• Administration should be done slowly, steadily and without interruption. If during the injection a resistance to the pressure of the piston is felt (possible indicator of obstruction of the needle due to the formation of crystalline agglomerates) or the patient experiences acute local pain, immediately interrupt the injection itself and remove the needle, let out a drop of product from the syringe without needle, insert a new needle and make a new injection.
• It is recommended to have it administered by an experienced medical or nursing staff.
• If not all the contents of the syringe are used, the remainder should be discarded and not reused.
Instructions for Use for the bottles
Powder for suspension for injection for intramuscular use : the suspension must be prepared extemporaneously by combining the solvent present in the package with the powder. Then shake the vial containing the suspension vigorously for a long time and draw into the syringe. The reconstituted suspension should be injected immediately after preparation.
Given the microcrystalline nature of Benzylpenicillin Benzatin, it is absolutely essential, to avoid serious embolic incidents (particularly in children) that the injection is given only after making sure that the needle has not accidentally entered a vein or artery.
For greater safety, it is suggested to this end, before injecting, to discard the needle used to fill the syringe and to insert a new needle only of No. 2 (21G) into the muscle mass, waiting at least 15 seconds to observe a " possible bleeding. Only if this is not the case, insert the syringe into the needle. Carry out the usual aspiration maneuver.
If during the injection a resistance to the pressure of the piston is felt (possible indicator of obstruction of the needle due to the formation of crystalline agglomerates) or the patient experiences acute local pain, immediately stop the injection itself and discard the liquid not yet used proceeding if necessary to give a new injection with a new needle and a new vial.
The choice of the type of needle to be replaced can follow the criteria indicated above. For this purpose, double needles of both types (18G and 21G) are supplied.
When repeated doses are required, the injection site should be changed from time to time.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to penicillins, cephalosporins, beta-lactam antibiotics. Infections caused by penicillinase-producing germs. Contraindicated in children less than 3 years of age (see sections 4.4 and 4.6).
04.4 Special warnings and appropriate precautions for use
In patients treated with penicillin-containing preparations, severe reactions such as anaphylactic shock may occur, more frequently by parenteral administration but also by oral administration. The most exposed subjects are those who from the history are sensitive to various allergens. Before starting a treatment with penicillin, it is therefore necessary to investigate any previous manifestations of hypersensitivity to penicillins and / or cephalosporins and, if they appear in the anamnesis, the drug should not be administered (see section 4.3). In case of a positive history of hypersensitivity to other allergens, on the other hand, the drug must be administered with extreme caution.
If allergic reactions occur during the course of treatment, the antibiotic should be discontinued and medications routinely used in these situations such as pressor amines, antihistamines and corticosteroids should be administered. Where necessary, vital functions should be supported by appropriate supportive measures.
The excretion of benzylpenicillin via the renal emunctorium is slowed in patients with renal insufficiency. High doses of? -Lactamines, especially in subjects with renal insufficiency, can give rise to metabolic encephalopathies with disturbances of consciousness, abnormal movements, seizures. If any of the above reactions occur, penicillin administration should be discontinued unless the disease being treated is life-threatening and sensitive only to penicillin therapy.
Injection into or near nerves or blood vessels is dangerous as it can cause neurovascular lesions. The physical and chemical characteristics of Benzylpenicillin Benzatin require particular attention to correct methods of use (see section 4.2) and recommend that its use be reserved for adults and children who are at least three years old. In the latter, moreover, the lateral side of the thigh will be preferred as the injection site (muscle vastus lateral of the quadriceps femoris).
Important information about some of the excipients:
The suspension for injection in pre-filled syringes contains para-hydroxy-benzoates, as preservatives, which can cause allergic reactions, even delayed ones, and exceptionally bronchospasm.
04.5 Interactions with other medicinal products and other forms of interaction
Administration of bacteriostatic antibiotics (e.g. erythromycin, tetracycline) can reduce the bactericidal effects of penicillins by slowing the rate of bacterial growth. It has been demonstrated in vitro that bactericidal agents are most effective when they act on the immature cell wall of rapidly proliferating microorganisms. However, the clinical significance of this interaction is not well documented. There are few clinical situations in which concomitant use of bacteriostatic and bactericidal antibiotics is indicated. However, in selected circumstances where such therapy is appropriate, the potential for interaction should be minimized by the use of adequate doses of antibacterials and by initiating treatment first. treatment with penicillin.
Blood levels of penicillin may be prolonged by concomitant administration of probenecid which blocks renal tubular secretion of penicillins.
04.6 Pregnancy and breastfeeding
Sigmacillin can be used in pregnancy. During lactation, the medicine should be administered in cases of real need and under the direct supervision of the doctor.
04.7 Effects on ability to drive and use machines
There is no known interference with the ability to drive and use machines.
04.8 Undesirable effects
Skin and subcutaneous tissue disorders: maculopapular rash, exfoliative dermatitis, urticaria, Quincke's edema, edema
Musculoskeletal and connective tissue disorders: arthralgia
General disorders and administration site conditions: hyperthermia, prostration
Disorders of the immune system: Serum sickness with chills, cases of Jarish-Herxheimer reaction, exceptionally anaphylactic shock, have been reported in antiluetic treatments
Gastrointestinal disorders: glossitis, stomatitis, nausea, vomiting, diarrhea (more frequent following oral administration)
Disorders of the blood and lymphatic system: anemia, thrombocytopenia, leukopenia, eosinophilia (usually following high doses)
Diagnostic tests: increased transaminases
04.9 Overdose
Overdose can lead to neurological adverse reactions, with elevated levels of beta-lactams in the CSF. In case of overdose, institute symptomatic treatment and take supportive measures.
Benzylpenicillin is hemodialysable.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterials for systemic use, penicillins sensitive to beta-lactamases; ATC code: J01CE08
Benzylpenicillin Benzatin is chemically the "3,3-dimethyl-7-oxo-6- (2-phenylacetamido) -4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid compound with N, N" - dibenzylethylenediamine (2: 1) tetrahydrate.
Benzylpenicillin Benzatin is prepared by the reaction of dibenzylethylenediamine with 2 molecules of Benzylpenicillin.
Benzylpenicillin is bactericidal against penicillin-sensitive microorganisms in the phase of active multiplication. It works by inhibiting the biosynthesis of cell wall mucopeptides. It is not active against the bacteria that produce penicillinase.
Benzylpenicillin exerts a "bactericidal action against numerous Gram-positive and some Gram-negative bacteria including: Staphylococcus, Streptococcus (group A), Pneumococcus, Neisseria gonorrhoeae, Treponema pallidum, Corynebacterium diphtheriae, Bacillus anthracis, Clostridium, Actinomyces, Streptobacillus moniliformis, Listeria monocytogenes, Leptospira.
05.2 Pharmacokinetic properties
Benzylpenicillin Benzatin injected intramuscularly is very slowly absorbed into the bloodstream and hydrolyzed to Benzylpenicillin: this results in low blood levels, but more persistent than those of other parenteral penicillins.
Penicillins bind to serum proteins, mainly albumin. Therapeutic levels of penicillins are readily attainable under normal conditions in the extracellular fluid and most other body tissues.
Penicillins are distributed in varying degrees in the pleural, pericardial, peritoneal, ascitic, synovial and interstitial fluid. Penicillins are excreted in breast milk.
The passage into the cerebrospinal fluid, eyes and prostate is limited.
Benzylpenicillin is rapidly excreted in the urine by glomerular filtration and active tubular secretion mainly in active form.
05.3 Preclinical safety data
Preclinical data are of little clinical relevance in light of the extensive experience acquired with the use of benzylpenicillin benzylpenicillin in humans.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Powder and solvent for suspension for injection for intramuscular use:
The vial of powder contains: Lecithin; Polysorbate.
The solvent vial contains: water for injections.
Powder for suspension for injection for intramuscular use:
Lecithin; Polysorbate.
Suspension for injection for intramuscular use: Lecithin; Povidone; Sodium citrate; Sodium caramelose; Propyl parahydroxybenzoate E216; Methyl parahydroxybenzoate E218; Water for injections.
06.2 Incompatibility
There are no known incompatibilities with other substances.
06.3 Period of validity
Powder and solvent for suspension for injection for intramuscular use:
Powder for suspension for injection for intramuscular use:
3 years
Suspension for injection for intramuscular use:
24 months
06.4 Special precautions for storage
SYRINGES
Suspension for injection for intramuscular use:
Store at 2 ° C to 8 ° C (refrigerated) in the original packaging for
protect the medicine from light.
BOTTLES
Powder and solvent for suspension for injection for intramuscular use
Powder for suspension for injection for intramuscular use
Store at a temperature not exceeding 25 ° C in the original packaging to repair the
medicine from the light.
The reconstituted suspension should be injected immediately after preparation.
06.5 Nature of the immediate packaging and contents of the package
SYRINGES
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection.
Glass pre-filled syringe with rubber closure;
packaging: 1 Syringe + 4 sterile needles; 2 Syringes + 8 sterile needles; 6 Syringes + 24 sterile needles (18G and 21G)
BOTTLES
Sigmacillin 600,000 I.U./2.5 ml powder and solvent for suspension for injection.
Glass vial with rubber and aluminum closure, 2.5 ml neutral glass vial;
package: a vial of powder + a solvent vial
Sigmacillin 600,000 I.U. powder for suspension for injection.
Glass vial with rubber and aluminum closure;
packaging: 50 vials of powder; 100 vials of powder
Sigmacillin 1,200,000 I.U./4 ml powder and solvent for suspension for injection.
Glass vial with rubber and aluminum closure, 4 ml neutral glass vial;
package: a vial of powder + a solvent vial
Sigmacillin 1,200,000 I.U. powder for suspension for injection.
Glass vial with rubber and aluminum closure;
packaging: 50 vials of powder; 100 vials of powder
06.6 Instructions for use and handling
None in particular.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Biopharma S.r.l. - Via Paolo Mercuri, 8 - 00193 Rome - Italy
08.0 MARKETING AUTHORIZATION NUMBER
Sigmacillin 600,000 I.U./2.5 ml Powder and solvent for suspension for injection for intramuscular use - 1 vial powder + 1 vial of 2.5 ml solvent AIC 033120015
Sigmacillin 600,000 I.U. Powder for suspension for injection for intramuscular use - 50 vials of powder AIC 033120039
Sigmacillin 600,000 I.U. Powder for suspension for injection for intramuscular use - 100 vials of powder AIC 033120041
Sigmacillin 1,200,000 I.U./4 ml Powder and solvent for suspension for injection for intramuscular use - 1 vial of powder + 1 vial of 4 ml solvent AIC 033120027
Sigmacillin 1,200,000 I.U. Powder for suspension for injection for intramuscular use - 50 vials of powder AIC 033120054
Sigmacillin 1,200,000 I.U. Powder for suspension for injection for intramuscular use - 100 vials of powder AIC 033120066
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection for intramuscular use - 1 pre-filled syringe of 2.5 ml AIC 033120092
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection for intramuscular use - 2 pre-filled syringes of 2.5 ml AIC 033120104
Sigmacillin 1,200,000 I.U./2.5 ml suspension for injection for intramuscular use - 6 pre-filled syringes of 2.5 ml AIC 033120116
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Bottles: December 14, 1998
Pre-filled syringes: May 23, 2011
10.0 DATE OF REVISION OF THE TEXT
July 2015
