Each 10 ml contains :
Iron (II) chloride tetrahydrate: 6.958 mg,
Zinc chloride: 6.815 mg
Manganese (II) chloride tetrahydrate: 1.979 mg
Copper (II) chloride dihydrate: 2.046 mg
Chrome (III) chloride hexahydraet: 0.053 mg
Sodium molypdate dihydrate: 0.0242 mg
Sodium selenite pentahydrate: 0.0789 mg
Sodium fluoride: 1.260 mg
Potassium iodide: 0.166mg

Concentrated solution for infusion

Supply of trace elements during parenteral nutrition in adults

Reserved for adults.

Dosage

The recommended daily dosage is 10 ml (1 ampoule) for patients with standard needs.

For patients with moderately increased needs, the daily dose can be up to 20 ml (2 ampoules), by monitoring serum trace element concentrations.

If there is a significant increase in micronutrient requirements (extended burns, polytrauma, severe hypercatabolism), higher doses may be required.

Pediatric population

TRAINFU is contraindicated in neonates, infants and children.

TRAINFU is not recommended for adolescents.

Patients with renal and hepatic impairment

For patients with impaired renal and / or hepatic function, doses should be determined on a case-by-case basis. For these patients, lower doses may be needed.

Method of administration

TRAINFU is a concentrated solution of micronutrients, which should only be administered intravenously after dilution in at least 250 ml of a compatible infusion solution, for example:

A glucose solution (at 5% or 10%)

An electrolyte solution (for example: 0.9% sodium chloride, Ringer's solution).

The compatibility should be tested before mixing with other solutions for infusion.

The infusion time of the ready-to-use mixture should not be less than 6 hours and should not be longer than 24 hours.

Administration may be continued for the duration of parenteral nutrition.

For incompatibilities and instructions for use.

Remarks

Diarrhea can lead to increased bowel intestinal losses. In this case, serum concentrations should be monitored.

Deficiencies in trace elements must be corrected by specific supplementation.

Carbetocin 100mcg/1ml

Solution for injection

Indicated for the prevention of uterine atony following delivery of the infant by Caesarean section under epidural or spinal anaesthesia

Withdraw 1 ml of PABAL containing 100 micrograms carbetocin and administer only by intravenous injection, under adequate medical supervision in a hospital.

Levobupivacaine (as Levobupivacaine hydrochloride) 50mg/10ml

Solution for injection

Adults
Surgical anaesthesia
• Major, e.g. epidural (including for caesarean section), intrathecal, peripheral nerve block.
• Minor, e.g. local infiltration, peribulbar block in ophthalmic surgery.
Pain management
• Continuous epidural infusion, single or multiple bolus epidural administration for the management of pain especially post-operative pain or labour analgesia.

Paediatric population
Analgesia (ilioinguinal/iliohypogastric blocks).

Levobupivacaine should be administered only by, or under the supervision of, a clinician having the necessary training and experience.

The table below is a guide to dosage for the more commonly used blocks. For analgesia (e.g. epidural administration for pain management), the lower concentrations and doses are recommended. Where profound or prolonged anaesthesia is required with dense motor block (e.g. epidural or peribulbar block), the higher concentrations may be used. Careful aspiration before and during injection is recommended to prevent intravascular injection.

There is limited safety experience with levobupivacaine therapy for periods exceeding 24 hours. In order to minimise the risk for severe neurological complications, the patient and the duration of administration of levobupivacaine should be closely monitored

Aspiration should be repeated before and during administration of a bolus dose, which should be injected slowly and in incremental doses, at a rate of 7.5–30 mg/min, while closely observing the patient's vital functions and maintaining verbal contact.

If toxic symptoms occur, the injection should be stopped immediately.

Maximum dose

The maximum dosage must be determined by evaluating the size and physical status of the patient, together with the concentration of the agent and the area and route of administration. Individual variation in onset and duration of block does occur. Experience from clinical studies shows onset of sensory block adequate for surgery in 10-15 minutes following epidural administration, with a time to regression in the range of 6-9 hours.

The recommended maximum single dose is 150 mg. Where sustained motor and sensory block are required for a prolonged procedure, additional doses may be required. The maximum recommended dose during a 24 hour period is 400 mg. For post-operative pain management, the dose should not exceed 18.75 mg/hour.

Obstetrics

For caesarean section, higher concentrations than the 5.0 mg/ml solution should not be used

The maximum recommended dose is 150 mg.

For labour analgesia by epidural infusion, the dose should not exceed 12.5 mg/hour.

Paediatric population

In children, the maximum recommended dose for analgesia (ilioinguinal/iliohypogastric blocks) is 1.25 mg/kg/side. The maximum dosage should be adjusted according to the size, body constitution and physical status of the patient/child.

The safety and efficacy of levobupivacaine in children for other indications have not been established.

Special populations

Debilitated, elderly or acutely ill patients should be given reduced doses of levobupivacaine commensurate with their physical status.

In the management of post-operative pain, the dose given during surgery must be taken into account.

There are no relevant data in patients with hepatic impairment

Nicardipine hydrochloride 10mg/10ml

Solution for injection

Treatment of acute life-threatening hypertension, particularly in the event

Adults

- Initial dose: Treatment should start with the continuous administration of nicardipine at a rate of 3-5 mg/h for 15 minutes. Rates can be increased by increments of 0.5 or 1 mg every 15 minutes. The infusion rate should not exceed 15 mg/h.

- Maintenance dose: When the target pressure is reached, the dose should be reduced progressively, usually to between 2 and 4 mg/h, to maintain the therapeutic efficacy.

Transition to an oral antihypertensive agent: discontinue nicardipine or titrate downward while appropriate oral therapy is established. When an oral antihypertensive agent is being instituted, consider the lag time of onset of the oral agent's affect. Continue blood pressure monitoring until desired effect is achieved.

A switch can also be made to oral nicardipine 20mg capsules at dosage of 60 mg/day in 3 daily doses, or to nicardipine 50 mg extended-release tablets, at dosage of 100mg/day, in 2 daily doses.

Elderly

- Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

- Elderly patients may be more sensitive to nicardipine effects because of impaired renal and/or hepatic function. It is recommended to provide a continuous infusion of nicardipine starting at the dose of 1 to 5 mg/h, depending on the blood pressure and clinical situation. After 30 minutes, depending on the effect observed, the rate should be increased or decreased by increments of 0.5 mg/h. The rate should not exceed 15 mg/h.

Paediatric population

- The safety and efficacy in low birth weight infants, newborns, nursing infants, infants, and children has not been established.

- Nicardipine should only be used for life-threatening hypertension in paediatric intensive care settings or post-operative contexts.

- Initial dose: In case of emergency, a starting dose of 0.5 to 5 mcg/kg/min is recommended.

- Maintenance dose: The maintenance dosage of 1 to 4 mcg/kg/min is recommended.

- Nicardipine should be used with particular caution in children with renal impairment. In this case, only the lowest dose should be used.

Pregnancy

It is recommended to provide a continuous infusion of nicardipine starting at 1 to 5 mg/h, depending on the blood pressure and clinical situation. After 30 minutes, depending on the effect observed, this rate can be increased or decreased by increments of 0.5 mg/h.

Doses higher than 4mg/h are generally not exceeded in the treatment of pre-eclampsia, however the rate should not exceed 15 mg/h. (See sections 4.4, 4.6 and 4.8)

Hepatic Impairment

Nicardipine should be used with particular caution in these patients. Since nicardipine is metabolized in the liver, it is recommended to use the same dose regimens as for elderly patients in patients with impaired liver function or reduced hepatic blood flow.

Renal Impairment

Nicardipine should be used with particular caution in these patients. In some patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) have been observed. Therefore, it is recommended to use the same dose regimens as for elderly patients in patients with renal impairment.

Fondaparinux sodium 2.5 mg/0.5 ml

Solution for injection

Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. 
Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery 
Prevention of Venous Thromboembolic Events (VTE) in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease. 
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in adults for whom urgent (< 120 mins) invasive management (PCI) is not indicated 
Treatment of ST segment elevation myocardial infarction (STEMI) in adults who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 
Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis

Fluconazole 2mg/ml

Soft Bag injection

Fluconazole is indicated in the following fungal infections
Fluconazole is indicated in adults for the treatment of:
▪ cryptococcal meningitis;
▪ coccidioidomycosis;
▪ invasive candidiasis;
▪ mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis;
▪ chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
Fluconazole is indicated in adults for the prophylaxis of:
▪ relapse of cryptococcal meningitis in patients with high risk of recurrence;
▪ relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse;
▪ prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation).
Fluconazole is indicated in term newborn infants, infants, toddlers, children and adolescents aged from 0 to 17 years old:
▪ Fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence.
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Consideration should be given to official guidance on the appropriate use of antifungals.

Sodium chloride 0.9%

Solution for injection

For use in prophylactic and replacement therapy, requiring the use of isotonic saline solution.
In the reconstitution, dilution and making up of certain drugs.
Use as a saline irrigant or as a priming fluid for haemodialysis procedures and to initiate and terminate blood transfusions.

Furosemide 10mg/ml

Solution for injection

Use BFS-Furosemid in case of:
- Oedema caused by cardiac or hepatic diseases
- Oedema caused by renal diseases (in case of nephrotic syndrome, treatment of the underlying disease is essential)
- Pulmonary oedema (e.g. in case of acute heart failure)

The parenteral administration of furosemide is indicated in cases where oral administration is not feasible or not efficient (for example in case of reduced intestinal absorption) or when a quick effect is required. To achieve optimum efficacy and suppress counter-regulation, a continuous furosemide infusion is generally to be preferred to repeated bolus injections.

Where continuous furosemide infusion is not feasible for follow-up treatment after one or several acute bolus doses, a follow-up regimen with low doses given at short intervals (approx. 4 hours) is to be preferred to a regimen with higher bolus doses at longer intervals.

Intravenous furosemide must be injected or infused slowly; a rate of 4 mg per minute must not be exceeded and should never be given in association with other medicinal products in the same syringe.

Generally, Furosemide should be administered intravenously. Intramuscular administration must be restricted to exceptional cases where neither oral nor intravenous administration is feasible. It must be noted that intramuscular injection is not suitable for the treatment of acute conditions such as pulmonary oedema.

Atosiban 7.5 mg/ml

Solution for injection

Atosiban is indicated to delay imminent pre-term birth in pregnant women with:
− regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes
− a cervical dilation of 1 to 3 cm (0-3 for nulliparas) and effacement of ≥ 50%
− a gestational age from 24 until 33 completed weeks
− a normal foetal heart rate

Treatment with Atosiban should be initiated and maintained by a physician experienced in the treatment of pre-term labour.

Atosiban is administered intravenously in three successive stages: an initial bolus dose (6.75 mg), performed with Atosiban 6.75 mg/0.9 ml solution for injection, immediately followed by a continuous high dose infusion (loading infusion 300 micrograms/min) of Atosiban 37.5 mg/5 ml concentrate for solution for infusion during three hours, followed by a lower dose of Atosiban 37.5 mg/5 ml concentrate for solution for infusion (subsequent infusion 100 micrograms/min) up to 45 hours. The duration of the treatment should not exceed 48 hours. The total dose given during a full course of Atosiban therapy should preferably not exceed 330.75 mg of atosiban.

Intravenous therapy using the initial bolus injection should be started as soon as possible after diagnosis of pre-term labour. Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Atosiban 37.5 mg/5 ml, concentrate for solution for infusion). In the case of persistence of uterine contractions during treatment with Atosiban, alternative therapy should be considered.

Carbazochrome sodium sulfonate 50mg/10ml

Solution for injection

Hemorrhagic tendency (purpura etc.) due to decreased capillary resistance and increased capillary permeability. 
Hemorrhage from skin, mucous membrane and internal membrane, hemorrhage at eyeground, nephrotic hemorrhage and metrorrhagia. 
Abnormal bleeding during and after operation due to decrease of capillary resistance.

Normal dose for adults is 25-100 mg daily, injection or infusion.
The dose should be up to the age and the severity of the disease.

Carbazochrome sodium sulfonate 25mg/5ml

Solution for injection

Hemorrhagic tendency (purpura etc.) due to decreased capillary resistance and increased capillary permeability. 
Hemorrhage from skin, mucous membrane and internal membrane, hemorrhage at eyeground, nephrotic hemorrhage and metrorrhagia. 
Abnormal bleeding during and after operation due to decrease of capillary resistance

Normal dose for adults is 25-100 mg daily, injection or infusion.
The dose should be up to the age and the severity of the disease.

Milrinone 10mg/10ml

Solution for injection

Indicated for the short-term treatment of severe congestive heart failure unresponsive to conventional maintenance therapy, and for the treatment of patients with acute heart failure, including low output states following cardiac surgery. In paediatric population, indicated for the short-term treatment (up to 35 hours) of severe congestive heart failure unresponsive to conventional maintenance therapy (glycosides, diuretics, vasodilators and/or angiotensin converting enzyme (ACE) inhibitors), and for the short-term treatment (up to 35 hours) of paediatric patients with acute heart failure, including low output states following cardiac surgery.