Paracetamol Galenica Senese

PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL GALENICA SENESE 10 mg/ml infusion solution

Paracetamol
Generic medicine
For children and adults weighing more than 33 kg (approximately 11 years of age)
Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What PARACETAMOL GALENICA SENESE is and what it is used for.
2. What you need to know before using PARACETAMOL GALENICA SENESE.
3. How to use PARACETAMOL GALENICA SENESE.
4. Possible side effects.
5. How to store PARACETAMOL GALENICA SENESE.
6. Further information.

1. WHAT PARACETAMOL GALENICA SENESE IS AND WHAT IT IS USED FOR

This medicinal product is an analgesic (relieves pain) and antipyretic (reduces fever).
It is indicated for the short-term treatment of moderate pain, particularly following surgical procedures, and for the short-term treatment of feverish conditions.
The 100 ml pack size is intended for adults, adolescents, and children with a body weight above 33 kg (approximately 11 years of age).

2. WHAT YOU SHOULD KNOW BEFORE USING PARACETAMOL GALENICA SENESE

Do not use Paracetamol GALENICA SENESE:

• If you are allergic (hypersensitive) to paracetamol or to any of the excipients in Paracetamol GALENICA SENESE.
• If you are allergic (hypersensitive) to propacetamol (another analgesic which is a paracetamol precursor).
• If you have severe liver disease.

Take special care with Paracetamol GALENICA SENESE:

• If you have liver or kidney problems, or if you are an alcohol abuser;
• If you are taking other medicines containing paracetamol;
• If you have nutritional problems (malnutrition) or dehydration.

Inform your doctor before starting treatment if any of the above conditions apply to you.
Oral analgesic therapy is recommended as soon as this route of administration becomes feasible.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamol GALENICA SENESE.
Use of other medicines
This medicine contains paracetamol. This must be taken into account if you are taking other medicines containing paracetamol or propacetamol, so as not to exceed the recommended daily dose (see next section). Inform your doctor if you are taking other medicines containing paracetamol. This medicine should not be administered if you are already taking other medicines containing paracetamol or propacetamol.
A dose reduction is recommended during concomitant treatment with probenecid.
Inform your doctor or pharmacist if you are taking oral anticoagulants. More frequent monitoring may be required to observe the effect of anticoagulant therapy.
Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (metabolic acidosis with high anion gap), which requires urgent treatment and may particularly occur in cases of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those without a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If necessary, Paracetamol GALENICA SENESE may be used during pregnancy.
The lowest possible dose that relieves pain and/or fever should be used for the shortest possible duration. Contact your doctor if pain and/or fever do not improve or if you need to take the medicine more frequently.
Paracetamol GALENICA SENESE may be used during breastfeeding.
Driving and using machines
Paracetamol GALENICA SENESE does not impair the ability to drive or operate machinery.
Important information about some excipients in Paracetamol Galenica Senese
This medicine contains less than 1 mmol of sodium (23 mg) per 100 ml of Paracetamol GALENICA SENESE, i.e. it is practically “sodium-free”.

3. HOW TO USE PARACETAMOLO GALENICA SENESE

Paracetamolo Galenica Senese will be administered to you by a healthcare professional.
Dosage
The dose will depend on your body weight (please refer to the table below) and your overall health status.
Your doctor will calculate your body weight and determine the dose you should receive.
Paracetamolo Galenica Senese must not be administered to children with a body weight < 33 kg.

The minimum interval between each treatment must be at least 4 hours.
The minimum interval between each treatment in patients with severe renal impairment must be at least 6
hours.
No more than 4 doses to be administered within 24 hours.
Method of administration
Intravenous use.
RISK OF PRESCRIBING ERRORS
Take care to avoid prescribing errors by confusing milligrams (mg) with millilitres (ml), which may result
in accidental overdose and death.
For the 100 ml bag: before administration, remove the outer protective covering.
Paracetamol Galenica Senese will be administered to you by intravenous infusion. The infusion will last
approximately 15 minutes.
If you feel that the effect of the medicine is too strong or too weak, discuss this with your doctor.
In case of overdose, symptoms generally appear within the first 24 hours and include: nausea, vomiting,
anorexia, pallor, abdominal pain and risk of liver damage. Due to the risk of irreversible liver damage, you
must seek immediate medical advice in case of overdose. Inform your doctor if you experience any of these
symptoms.
If you have any doubts about the use of Paracetamol Galenica Senese, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Paracetamol Galenica Senese may cause adverse reactions, although not everybody experiences them.
In rare cases (affecting 1 to 10 patients in 10,000), the following may occur: malaise, low blood pressure, or changes in laboratory test results (abnormal elevated levels of liver enzymes detected during blood tests). If this occurs, inform your doctor, as regular blood tests may subsequently be required.
In very rare cases (affecting fewer than 1 in 10,000 patients), skin rash or severe allergic reaction ( skin redness, flushing, itching, and irregular increase in heart rate ) may occur. Immediately discontinue treatment and inform your doctor.
In very rare cases, other abnormalities in laboratory tests have been observed, requiring regular blood tests: irregular low levels of certain types of blood cells (platelets, white blood cells) may occur, possibly leading to bleeding from the nose or gums. If this occurs, inform your doctor.
During clinical studies, frequent adverse reactions at the injection site (pain and burning sensation) have been reported.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your physician or pharmacist.
You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PARACETAMOL GALENICA SENESE

Keep Paracetamol Galenica Senese out of the reach and sight of children.
Do not use Paracetamol Galenica Senese after the expiry date stated on the packaging after "Exp."
The expiry date refers to the last day of the month.
Glass vials: do not refrigerate or freeze. Store in the original packaging to protect the medicine from light.
Plastic bags: do not store at temperatures above 25°C. Do not refrigerate or freeze. To protect the medicine from light, store the plastic bag in the outer aluminum overwrap.
After removal of the outer overwrap, the medicine must be used immediately.
For single use only. After opening, the product must be used immediately. Any unused solution must be discarded.
Before administration, the product should be inspected visually. Do not use Paracetamol Galenica Senese if the solution shows changes in colour or if particulate matter is present.
Medicines must 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.

6. OTHER INFORMATION

What Paracetamolo Galenica Senese contains

• The active substance is paracetamol. One ml contains 10 mg of paracetamol. This packaging contains 1000 mg of paracetamol in 100 ml.
• The excipients are mannitol (E-421), monosodium phosphate dihydrate, sodium hydroxide (to adjust pH), povidone K-12, and water for injections.

Description of the appearance of Paracetamolo Galenica Senese and contents of the pack
Paracetamolo Galenica Senese is a clear, slightly yellowish infusion solution.
Paracetamolo Galenica Senese is available in packs containing 1, 10 and 12 vials or in packs containing 10 and 20 plastic bags with an outer aluminium foil overwrap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351
53014 Monteroni d’Arbia (Siena)
Italy
This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy: Paracetamolo Galenica Senese 10 mg/ml solution for infusion.
This summary of product characteristics was last approved on --------------------------------------------------------------

The following information is intended exclusively for physicians or healthcare professionals:

1. NAME OF THE MEDICINAL PRODUCT

Paracetamol Galenica Senese 10 mg/ml Solution for infusion.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial/bag contains 1000 mg of paracetamol.
One ml contains 10 mg of paracetamol.
Excipients: Sodium 0.02 mg/ml.
For the complete list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for infusion.
The solution is clear and slightly yellowish.
pH: 5.0–6.5
Osm: 270–300 mOsm

4. CLINICAL INFORMATION

4.1 Therapeutic indications
Paracetamol Galenica Senese is indicated for the short-term treatment of moderate-intensity pain, particularly following surgical intervention, and for the short-term treatment of febrile conditions, when intravenous administration is clinically justified by the urgent need to treat pain or hyperthermia and/or when other routes of administration are impossible to implement.

4.2 Posology and method of administration
For intravenous use only.
This medicinal product is intended for use in adults, adolescents, and children with a body weight above 33 kg (approximately 11 years of age).
Posology: the dosage is proportional to the patient's body weight (please refer to the table below):

The minimum interval between each treatment must be at least 4 hours.
No more than 4 doses to be administered within 24 hours.
Severe renal impairment: the minimum interval between doses in patients with severe renal
impairment (creatinine clearance  30 ml/min) must be at least 6 hours (see
section 5.2).
In adults with hepatic insufficiency, chronic alcoholism, chronic malnutrition (low hepatic glutathione reserves), or dehydration: the maximum daily dose must not exceed 3 g (see section 4.4).

Method of administration:
Exercise caution when prescribing and administering Paracetamolo Galenica Senese to avoid dosing errors between milligrams (mg) and milliliters (ml), which may result in accidental overdose and death. Ensure correct communication and dispensing of the prescribed dose. When writing a prescription, always specify both the total dose in mg and the total volume. Confirm that the dose is correctly calculated and measured.

Paracetamol solution is administered as a 15-minute intravenous infusion.
Before administration, visually inspect the medicinal product for particulate matter and discoloration. For single use only.

As with all intravenous infusion solutions, careful monitoring is required, especially at the end of the infusion, regardless of the route of administration. To prevent gaseous embolism, monitoring at the end of the infusion is particularly necessary for central line infusions.

4.3 Contraindications
Paracetamolo Galenica Senese is contraindicated:

• in patients with hypersensitivity to paracetamol or propacetamol hydrochloride (a prodrug of paracetamol), or to any of the excipients;
• in cases of severe hepatic insufficiency.

4.4 Special warnings and precautions for use
Warnings
RISK OF PRESCRIBING ERRORS
Take care to avoid prescribing errors due to confusion between milligrams (mg) and milliliters (ml), which may lead to accidental overdose and death (see section 4.2).
It is recommended to switch to an appropriate oral analgesic treatment as soon as this route becomes feasible.
To avoid the risk of overdose, ensure that no other concurrently administered medication contains paracetamol or propacetamol.
Doses higher than those recommended may result in severe liver damage. Clinical signs and symptoms of liver injury (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis) generally do not appear until at least two days after administration, with a peak incidence observed after 4–6 days. Antidotal treatment should be administered as soon as possible (see section 4.9).
This medicinal product contains less than 1 mmol of sodium (23 mg) per 100 ml of Paracetamolo Galenica Senese, i.e., it is practically “sodium-free”.

Precautions for use
Paracetamol should be used with caution in the following conditions:

• hepatic insufficiency;
• severe renal impairment (creatinine clearance  30 ml/min) (see sections 4.2 and 5.2);
• chronic alcoholism;
• chronic malnutrition (low hepatic glutathione reserves);
• dehydration;
• Caution is advised when paracetamol is administered concomitantly with flucloxacillin due to an increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition, and other sources of glutathione deficiency (e.g., chronic alcoholism), as well as in those receiving the maximum daily dose of paracetamol. Close monitoring, including assessment of urinary 5-oxoproline, is recommended.

4.5 Interaction with other medicinal products and other forms of interaction

• Probenecid reduces the clearance of paracetamol by approximately two-fold by inhibiting its glucuronidation. When paracetamol is co-administered with probenecid, a reduced dose of paracetamol should be considered.
• Salicylamide may prolong the elimination half-life of paracetamol.
• Caution is required when paracetamol is taken concomitantly with enzyme inducers (see section 4.9).
• Concomitant use of paracetamol (4 g daily for at least 4 days) with oral anticoagulants may lead to slight changes in INR values. In such cases, close monitoring of INR values is required during concomitant use and for one week after discontinuation of paracetamol treatment.
• Caution is required when paracetamol is used concomitantly with flucloxacillin, as concomitant administration has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4).

4.6 Pregnancy and lactation
Pregnancy:
Clinical experience with intravenous administration of paracetamol is limited. However, epidemiological data on the oral use of therapeutic doses of paracetamol show no adverse effects during pregnancy or on fetal/neonatal health.
Prospective data on pregnancies exposed to paracetamol overdose have not shown an increased risk of malformations.
Reproductive studies in animals have not been conducted with the intravenous form of paracetamol. However, studies with the oral form have shown no teratogenic or fetotoxic effects.
Nevertheless, Paracetamolo Galenica Senese should be used during pregnancy only after careful assessment of the benefit-risk ratio. In such cases, the recommended dosage and duration of treatment must be strictly observed.

Lactation
After oral administration, paracetamol is excreted in breast milk in small amounts. No adverse effects have been reported in breastfed infants. Therefore, Paracetamolo Galenica Senese may be used in breastfeeding women.

4.7 Effects on ability to drive and use machines
Not relevant.

4.8 Undesirable effects
As with all paracetamol-containing medicinal products, adverse drug reactions are rare ( 1/10,000 to < 1/1,000) or very rare (< 1/10,000). They are described below:

Classification by system organ
Rare Very rare
Haematopoietic system disorders Thrombocytopenia, Neutropenia Leukopenia
Vascular disorders Hypotension
Hepatobiliary disorders Increased levels of hepatic transaminases
General disorders and administration site conditions Malaise Hypersensitivity reaction

Very rare cases of hypersensitivity reactions have been reported, ranging from simple skin rash or urticaria to anaphylactic shock, requiring immediate discontinuation of treatment.
Cases of erythema, flushing, pruritus, and tachycardia have also been reported.
Frequent adverse reactions at the injection site (pain, burning sensation) have been reported in clinical trials.

4.9 Overdose
There is an increased risk of liver damage (including fulminant hepatitis, hepatic failure, cholestatic hepatitis, cytolytic hepatitis), especially in elderly patients, young children, patients with liver disease, chronic alcoholics, patients with chronic malnutrition, and patients receiving enzyme inducers. In these cases, overdose may be fatal.
Symptoms generally appear within the first 24 hours and include: nausea, vomiting, anorexia, pallor, and abdominal pain.
An overdose of 7.5 g or more of paracetamol in a single dose in adults, or 140 mg/kg body weight in a single dose in children, causes hepatic cytolytic necrosis, which may lead to complete and irreversible necrosis, resulting in hepatic failure, metabolic acidosis, and encephalopathy, potentially progressing to coma and death.
Concurrently, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase, and bilirubin are observed, along with decreased prothrombin levels, which may become apparent between 12 and 48 hours after ingestion. Clinical signs of liver damage usually appear within two days and peak between 4 and 6 days after ingestion.

Emergency measures
Immediate hospitalization is required.
Before initiating treatment and as soon as possible after overdose, obtain a blood sample to determine plasma paracetamol levels.
Treatment includes administration of the antidote, N-acetylcysteine (NAC), either intravenously or orally, preferably within 10 hours. However, NAC may still provide some degree of protection even after 10 hours, although prolonged treatment is required in such cases.
Symptomatic treatment.
Liver function tests should be performed at the start of treatment and repeated every 24 hours. In most cases, hepatic transaminases return to normal within one or two weeks, with full recovery of liver function. However, in very severe cases, liver transplantation may be necessary.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic category: other analgesics and antipyretics; Anilides
ATC code: N02BE01

The exact mechanism of the analgesic and antipyretic properties of paracetamol has not yet been fully established; it may involve both central and peripheral actions.

Paracetamol Galenica Senese produces onset of pain relief within 5 to 10 minutes after the start of administration. The peak analgesic effect is achieved within one hour, and this effect normally lasts from 4 to 6 hours.

Paracetamol Galenica Senese reduces fever within 30 minutes after the start of administration, with the antipyretic effect lasting at least 6 hours.

5.2 Pharmacokinetic properties
Adults
Absorption
The pharmacokinetics of paracetamol is linear up to 2 g following single administration and repeated administrations within 24 hours.
The bioavailability of paracetamol after infusion of 500 mg and 1 g of paracetamol is similar to that observed after infusion of 1 g and 2 g of propacetamol (containing 500 mg and 1 g of paracetamol, respectively). The maximum plasma concentration (C_max) of paracetamol observed at the end of a 15-minute intravenous infusion of 500 mg and 1 g of paracetamol is approximately 15 μg/ml and 30 μg/ml, respectively.

Distribution
The volume of distribution of paracetamol is approximately 1 l/kg.
Paracetamol does not extensively bind to plasma proteins.
Following infusion of 1 g of paracetamol, significant concentrations of paracetamol (approximately 1.5 μg/ml) have been observed in cerebrospinal fluid 20 minutes after infusion.

Metabolism
Paracetamol is primarily metabolized in the liver via two major hepatic pathways: conjugation with glucuronic acid and conjugation with sulfuric acid. The latter pathway is rapidly saturated at doses exceeding therapeutic levels. A small fraction (less than 4%) is metabolized by cytochrome P450 into a reactive intermediate (N-acetyl-benzoquinone imine), which under normal conditions of use is rapidly detoxified by reduced glutathione and eliminated in urine after conjugation with cysteine and mercapturic acid. However, in massive overdoses, the amount of this toxic metabolite increases.

Elimination
Paracetamol metabolites are primarily excreted in urine. Ninety percent of the administered dose is excreted within 24 hours, mostly as glucuronide conjugates (60–80%) and sulfate conjugates (20–30%). Less than 5% is eliminated unchanged. The plasma half-life is 2.7 hours and total body clearance is 18 l/h.

Neonates, infants, and children
Pharmacokinetic parameters of paracetamol observed in infants and children are similar to those observed in adults, except for a slightly shorter plasma half-life (1.5–2 hours) compared to adults. In neonates, the plasma half-life is longer than in later infancy, approximately 3.5 hours. In neonates, infants, and children up to 10 years of age, significantly lower excretion of glucuronide conjugates and higher excretion of sulfate conjugates are observed compared to adults.

Table – Age-related pharmacokinetic values (standardized clearance, *CL/F (l·h⁻¹·70 kg⁻¹))

| Age | Weight (kg) | CL/F (l·h⁻¹·70 kg⁻¹) |
|--------|------------------|---------------------------|
| 40 weeks PCA | 3.3 | 5.9 |
| 3 months PNA | 6 | 8.8 |
| 6 months PNA | 7.5 | 11.1 |
| 1 year PNA | 10 | 13.6 |
| 2 years PNA | 12 | 15.6 |
| 5 years PNA | 20 | 16.3 |
| 8 years PNA | 25 | 16.3 |

*CL is the population-estimated value for CL.

Special populations
Renal impairment
In cases of severe renal impairment (creatinine clearance 10–30 ml/min), elimination of paracetamol is slightly delayed, with an elimination half-life ranging from 2 to 5.3 hours. The elimination rate of glucuronide and sulfate conjugates is three times slower in subjects with severe renal dysfunction compared to healthy subjects. Therefore, it is recommended to increase the minimum dosing interval to 6 hours when paracetamol is administered to patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) (see section 4.2).

Elderly subjects
The pharmacokinetics and metabolism of paracetamol are not altered in elderly subjects. Dose adjustment is not required in this population.

5.3 Preclinical safety data
Non-clinical data reveal no special risk for humans beyond the information included in other sections of the Summary of Product Characteristics.
Local tolerance studies of paracetamol in rats and rabbits showed good tolerability. In guinea pigs, the absence of delayed contact hypersensitivity was demonstrated.

6. PHARMACEUTICAL INFORMATION

6.1 List of excipients

• Mannitol
• Monosodium phosphate dihydrate
• Povidone K-12
• Sodium hydroxide – for pH adjustment
• Water for injections

6.2 Incompatibilities
Paracetamol Galenica Senese must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf life
18 months: plastic bags
36 months: glass vials
Chemical and physical in-use stability has been demonstrated for 15 days between 2°C and 8°C. From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C.

6.4 Special precautions for storage
Glass vials: Do not refrigerate, do not freeze. Store in the original packaging to protect the medicinal product from light.
Plastic bags: Do not store above 25°C. Do not store in the refrigerator, do not freeze. To protect the medicinal product from light, store the plastic bag within its outer aluminium overwrap. After removal of the outer overwrap, the medicinal product must be used immediately.

6.5 Nature and contents of the container
Glass vials:
Clear type II glass vials of 100 ml, with a stopper made of halogenated butyl rubber and sealed with an aluminium cap. Pack contents: 1, 10, 12, 20 and 48 vials.
Plastic bags:
100 ml bag made of polyolefins with one blind entry port and one entry port covered with an elastomeric stopper and sealed with a plastic cap. The bag and the entry ports are covered by an opaque aluminium overwrap sheet.
100 ml bag made of polyolefins with one or two entry ports covered with an elastomeric stopper and sealed with plastic caps. The bag and the entry ports are covered by an opaque aluminium overwrap sheet.
Pack contents: 10, 12 and 20 bags.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and handling
If diluted in 9 mg/ml (0.9%) sodium chloride or 50 mg/ml (5%) glucose, the solution must be used immediately. However, if the solution is not used immediately, it should be stored for no longer than one hour (including infusion time).
For the 100 ml bag: prior to administration, remove the outer overwrap.
Unused medicinal product and waste material must be disposed of in accordance with local applicable regulations.

7. MARKETING AUTHORISATION HOLDER

Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351
53014 - Monteroni d’Arbia (SI)
Italy

8. MARKETING AUTHORISATION NUMBERS

AIC n. 041160019 - "10 mg/ml Solution for Infusion" 1 Glass Vial of 100 ml
AIC n. 041160021 - "10 mg/ml Solution for Infusion" 10 Glass Vials of 100 ml
AIC n. 041160033 - "10 mg/ml Solution for Infusion" 12 Glass Vials of 100 ml
AIC n. 041160072 - "10 mg/ml Solution for Infusion" 20 Glass Vials of 100 ml
AIC n. 041160084 - "10 mg/ml Solution for Infusion" 48 Glass Vials of 100 ml
AIC n. 041160045 - "10 mg/ml Solution for Infusion" 10 Polyolefin Bags of 100 ml with two ports
AIC n. 041160058 - "10 mg/ml Solution for Infusion" 20 Polyolefin Bags of 100 ml with two ports
AIC n. 041160108 - "10 mg/ml Solution for Infusion" 12 Polyolefin Bags of 100 ml with two ports
AIC n. 041160060 - "10 mg/ml Solution for Infusion" 10 Polyolefin Bags of 100 ml with one port
AIC n. 041160096 - "10 mg/ml Solution for Infusion" 12 Polyolefin Bags of 100 ml with one port

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

14.02.2014/08.01.2018

10. DATE OF TEXT REVISION

31/10/2019