bhpardo/ema_en · Datasets at Hugging Face

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8.
-
72 10.
In particular, products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk, are likely to interfere with absorption of Bondenza, which is consistent with findings in animal studies.
LABELLING
The date the product is removed from the refrigerator and set at room temperature (not exceeding 25oC) and the date the bottle should be withdrawn should be noted on the outer carton.
LIST OF EXCIPIENTS
If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.
Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.
It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.
Manufacturer Roche Diagnostics GmbH Sandhoferstrasse 116 D-68305 Mannheim Germany.
Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy.
Adverse Drug Reaction Hypertension Rash/ Erythema
8.
There are no adequate data on the use of Apidra in pregnant women.
77 6.6 Special precautions for disposal and other handling
During PCI, monitoring of clotting time such as the ACT is recommended in patients with renal insufficiency.
The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).
Take it for as long as your doctor told you to.
Actrapid contains metacresol, which may cause allergic reactions.
Lot:
Tenofovir 300 mg QD (maraviroc 300 mg BID)
If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.
The efficacy of caspofungin against these fungal pathogens has not been established.
Boehringer Ingelheim Austria GmbH, Dr.
Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the dose required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection.
EXPIRY DATE
Remember that 78 units is the maximum dose
Your insulin will work more quickly if you inject it around the waist.
POSSIBLE SIDE EFFECTS
No case of overdose has been reported.
Patients should be monitored closely to ensure that the lowest approved dose of Epoetin alfa is used to provide adequate control of the symptoms of anaemia.
It might be necessary to postpone the vaccination until recovery.
France BRISTOL-MYERS SQUIBB SARL Tél: + 33 (0)810 410 500
OTHER
Lot
- disopyramide (used to treat certain heart conditions),
14.
Thromboembolic Events
3/ 3
2.
Luxembourg/ Luxemburg BRISTOL-MYERS SQUIBB BELGIUM S. A. / N. V.
Adverse events at very high doses were all considered to be related to an exaggerated pharmacological
Solvent: sodium chloride water for injections.
These measures will help to protect the environment.
For adjuvants, see section 2.
12.
EXP:
EU/ 1/ 03/ 258/ 007-009 EU/ 1/ 03/ 258/ 013 EU/ 1/ 03/ 258/ 017 EU/ 1/ 03/ 258/ 021
Immunization should be carried out by intramuscular injection into the deltoid muscle.
Method of administration
MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE
Solution for injection in a pre-filled syringe
A complete washout is essential in such cases.
• Quantity of Busilvex:
7.
(dose in mg)
Your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in your blood.
PHARMACEUTICAL FORM
37 1.
If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 25°C).
In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic fat.
For Aranesp no clinical data on exposed pregnancies are available.
Ελλάδα Ferrer-Galenica A.E.
36, Ctra.
No special requirements.
coagulopathies, coagulation and bleeding analyses abnormal, pancytopenia, neutropenia
With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.
Store in the original carton.
The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).
Iron supplementation should be started prior to epoetin alfa therapy, to achieve adequate iron stores.
Subcutaneous use
These frequencies have been estimated on a per- infusion basis and are described using the following categories: uncommon (≥ 1/ 1000 to ≤ 1/ 100); rare (≥ 1/ 10,000 to ≤ 1/ 1000).
In clinical studies, an increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).
- all other medicines to treat diabetes,
No dosage adjustment is necessary in elderly patients.
Pioglitazone will not affect your ability to drive or operate machinery.
The absolute bioavailability has not been determined.
12.
These data were generated with the former Ambirix formulation containing thiomersal and a preservative.
OTHER SPECIAL WARNING(S), IF NECESSARY
0.99, 1,18; 42 trials and 8167 patients).
Keep out of the reach and sight of children.
Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France
When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.
Manufacturer:
What benefit has Aprovel shown during the studies?
2.
Subcutaneous use
DATE OF REVISION OF THE TEXT
In the event of overdose, treatment should be symptomatic.
Otherwise, the liquid may leak out which can cause inaccurate dosing.
The advisability of driving should be considered in these circumstances.
Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr oral lyophilisate.
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Common: itching/ pruritus, rash, urticaria
• Pure Red Cell Aplasia.
EU/ 1/ 99/ 118/ 003 30 tablets EU/ 1/ 99/ 118/ 004 100 tablets
Uncommon (≥ 1/ 1,000 to < 1/ 100)
Store in a refrigerator.

8.

-

72 10.

In particular, products containing calcium and other multivalent cations (such as aluminium, magnesium, iron), including milk, are likely to interfere with absorption of Bondenza, which is consistent with findings in animal studies.

LABELLING

The date the product is removed from the refrigerator and set at room temperature (not exceeding 25oC) and the date the bottle should be withdrawn should be noted on the outer carton.

LIST OF EXCIPIENTS

If the haemoglobin exceeds 12 g/ dl (7.5 mmol/ l), a dose reduction should be considered.

Gastrointestinal, nervous system, haematological, renal and metabolic effects are generally associated with systemic carbonic anhydrase inhibitors.

It may harm them, even if their symptoms are the same as yours. – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, diabetes nurse or your pharmacist.

Manufacturer Roche Diagnostics GmbH Sandhoferstrasse 116 D-68305 Mannheim Germany.

Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy.

Adverse Drug Reaction Hypertension Rash/ Erythema

8.

There are no adequate data on the use of Apidra in pregnant women.

77 6.6 Special precautions for disposal and other handling

During PCI, monitoring of clotting time such as the ACT is recommended in patients with renal insufficiency.

The frequencies are defined as: uncommon (≥ 1/ 1,000 to < 1/ 100).

Take it for as long as your doctor told you to.

Actrapid contains metacresol, which may cause allergic reactions.

Lot:

Tenofovir 300 mg QD (maraviroc 300 mg BID)

If the rise in haemoglobin is greater than 2 g/ dl (1.25 mmol/ l) in 4 weeks, the dose should be reduced by 25 to 50%.

The efficacy of caspofungin against these fungal pathogens has not been established.

Boehringer Ingelheim Austria GmbH, Dr.

Data from 809 patients receiving Aranesp in European clinical studies were analysed to assess the dose required to maintain haemoglobin; no difference was observed between the average weekly dose administered via the intravenous or subcutaneous routes of injection.

EXPIRY DATE

Remember that 78 units is the maximum dose

Your insulin will work more quickly if you inject it around the waist.

POSSIBLE SIDE EFFECTS

No case of overdose has been reported.

Patients should be monitored closely to ensure that the lowest approved dose of Epoetin alfa is used to provide adequate control of the symptoms of anaemia.

It might be necessary to postpone the vaccination until recovery.

France BRISTOL-MYERS SQUIBB SARL Tél: + 33 (0)810 410 500

OTHER

Lot

- disopyramide (used to treat certain heart conditions),

14.

Thromboembolic Events

3/ 3

2.

Luxembourg/ Luxemburg BRISTOL-MYERS SQUIBB BELGIUM S. A. / N. V.

Adverse events at very high doses were all considered to be related to an exaggerated pharmacological

Solvent: sodium chloride water for injections.

These measures will help to protect the environment.

For adjuvants, see section 2.

12.

EXP:

EU/ 1/ 03/ 258/ 007-009 EU/ 1/ 03/ 258/ 013 EU/ 1/ 03/ 258/ 017 EU/ 1/ 03/ 258/ 021

Immunization should be carried out by intramuscular injection into the deltoid muscle.

Method of administration

MANUFACTURING AUTHORISATION HOLDERS RESPONSIBLE FOR BATCH RELEASE

Solution for injection in a pre-filled syringe

A complete washout is essential in such cases.

• Quantity of Busilvex:

7.

(dose in mg)

Your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in your blood.

PHARMACEUTICAL FORM

37 1.

If the product is still stored in a refrigerator, take both the ADVATE powder and solvent vials from the refrigerator and let them reach room temperature (between 15°C and 25°C).

In mechanistic studies, the weight increase was predominantly shown to be due to increased subcutaneous fat with decreased visceral and intra-hepatic fat.

For Aranesp no clinical data on exposed pregnancies are available.

Ελλάδα Ferrer-Galenica A.E.

36, Ctra.

No special requirements.

coagulopathies, coagulation and bleeding analyses abnormal, pancytopenia, neutropenia

With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.

Store in the original carton.

The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).

Iron supplementation should be started prior to epoetin alfa therapy, to achieve adequate iron stores.

Subcutaneous use

These frequencies have been estimated on a per- infusion basis and are described using the following categories: uncommon (≥ 1/ 1000 to ≤ 1/ 100); rare (≥ 1/ 10,000 to ≤ 1/ 1000).

In clinical studies, an increased risk of death, serious cardiovascular events, and vascular access thrombosis was observed when erythropoiesis-stimulating agents (ESAs) were administered to target a haemoglobin of greater than 12 g/ dl (7.5 mmol/ l).

- all other medicines to treat diabetes,

No dosage adjustment is necessary in elderly patients.

Pioglitazone will not affect your ability to drive or operate machinery.

The absolute bioavailability has not been determined.

12.

These data were generated with the former Ambirix formulation containing thiomersal and a preservative.

OTHER SPECIAL WARNING(S), IF NECESSARY

0.99, 1,18; 42 trials and 8167 patients).

Keep out of the reach and sight of children.

Novo Nordisk Production SAS 45, Avenue d’ Orléans F-28002 Chartres France

When substituting Aranesp for r-HuEPO the haemoglobin should be monitored every one or two weeks and the same route of administration should be used.

Manufacturer:

What benefit has Aprovel shown during the studies?

2.

Subcutaneous use

DATE OF REVISION OF THE TEXT

In the event of overdose, treatment should be symptomatic.

Otherwise, the liquid may leak out which can cause inaccurate dosing.

The advisability of driving should be considered in these circumstances.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Azomyr oral lyophilisate.

Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].

Common: itching/ pruritus, rash, urticaria

• Pure Red Cell Aplasia.

EU/ 1/ 99/ 118/ 003 30 tablets EU/ 1/ 99/ 118/ 004 100 tablets

Uncommon (≥ 1/ 1,000 to < 1/ 100)

Store in a refrigerator.